PAINT-ON-RESTORATIVE W/FISSURE SEALER— 510(k) K800391

Name: FDA 510(k) clearance K800391
Creator: U.S. Food and Drug Administration
Published: 1980-04-10

Substantially Equivalent

American Dental Research

FDA 510(k) clearance K800391 for PAINT-ON-RESTORATIVE W/FISSURE SEALER, Substantially Equivalent on 1980-04-10. Applicant: American Dental Research. Device class: 2.

Clearance details

Applicant: American Dental Research
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1980-02-20
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800392 — BRACKET BONDING SYSTEM METAL & PLASTIC1980-04-10
K800393 — POLY SULFIDE IMPRESSION PASTE W/CATALYST1980-04-10

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